Non-Muscle Invasive Bladder Cancer
Conditions
Brief summary
Cohort A: Comparison of the CR rate at 6 months for patients treated with N-803 plus BCG versus patients treated with BCG alone. Cohort B: The estimate of the median DFS will be provided for each treatment group along with the 95% confidence interval. Cohort A and B: Due to the allocation of a small amount of alpha to the unplanned interim efficacy analyses, the final primary efficacy analyses will be conducted at alpha level of 0.0499.
Detailed description
Cohort A 1. Duration of CR 2. CR rate at 3, 9, 12, 18, 24, 30, and 36 months Cohort B 1. DFS rate at 3, 9, 12, 18, 24, 30, and 36 months. Cohort A 1. CR rate at 3, 9, 12, 18, 24, 30, and 36 months (all recurrent bladder cancer including low grade Ta disease) 2. Duration of CR (all recurrent bladder cancer, including low grade Ta disease).
Interventions
DRUGN-803 (NAI)
DRUGOncoTICE® 2-8 x 108 vermehrungsfähige Einheiten Pulver zur Herstellung einer Suspension zur intravesikalen Instillation
Sponsors
Immunitybio Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cohort A: Comparison of the CR rate at 6 months for patients treated with N-803 plus BCG versus patients treated with BCG alone. Cohort B: The estimate of the median DFS will be provided for each treatment group along with the 95% confidence interval. Cohort A and B: Due to the allocation of a small amount of alpha to the unplanned interim efficacy analyses, the final primary efficacy analyses will be conducted at alpha level of 0.0499. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cohort A 1. Duration of CR 2. CR rate at 3, 9, 12, 18, 24, 30, and 36 months Cohort B 1. DFS rate at 3, 9, 12, 18, 24, 30, and 36 months. Cohort A 1. CR rate at 3, 9, 12, 18, 24, 30, and 36 months (all recurrent bladder cancer including low grade Ta disease) 2. Duration of CR (all recurrent bladder cancer, including low grade Ta disease). | — |
Countries
Germany
Outcome results
None listed